{"id":7904,"date":"2025-06-13T16:00:05","date_gmt":"2025-06-13T23:00:05","guid":{"rendered":"https:\/\/rakuten-med.com\/us\/?post_type=press_releases&#038;p=7904"},"modified":"2025-06-13T16:15:05","modified_gmt":"2025-06-13T23:15:05","slug":"rakuten-medical-selected-to-participate-in-fda-ceo-forum-in-san-diego","status":"publish","type":"press_releases","link":"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2025\/06\/13\/7904\/","title":{"rendered":"Rakuten Medical Selected to Participate in FDA CEO Forum in San Diego"},"content":{"rendered":"<div id=\"pl-7904\"  class=\"panel-layout\" ><div id=\"pg-7904-0\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7904-0-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7904-0-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<ul>\n<li><em><strong>Engaged with FDA Commissioner on shared commitment to fast, safe, and affordable patient access to innovative therapies<\/strong><\/em><\/li>\n<\/ul>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7904-1\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7904-1-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7904-1-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"1\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><b>San Diego, CA \u2013 <\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc., a global biotechnology company developing and commercializing Alluminox\u2122 platform-based photoimmunotherapy, today announced that it was selected by the U.S. Food and Drug Administration (FDA) to participate in the <\/span><a href=\"https:\/\/www.fda.gov\/industry\/ceo-forums-fda-listening-tour-engage-pharma-ceos\" target=\"_blank\" rel=\"noopener\"><span style=\"font-weight: 400\">FDA CEO Forum<\/span><\/a><span style=\"font-weight: 400\"> in San Diego, California, on June 13, 2025. Minami Maeda, President of Rakuten Medical, attended the meeting in person as a member of this panel, to discuss with FDA Commissioner Marty A. Makary, M.D., M.P.H., and other industry leaders how the FDA can \u201cmodernize its regulatory framework to better support innovation and patient access to safe and effective therapies\u201d.<\/span><\/p>\n<p>Rakuten Medical \u2013 whose innovative cancer therapeutic technology, the Alluminox\u2122 platform, is in Phase 3 trials in the U. S. \u2013 was selected to join the forum as one of the companies at the front lines of medical discovery. Rakuten Medical\u2019s novel treatment modality, known as photoimmunotherapy, is designed to induce rapid and selective depletion of cancer or immunosuppressive cells with minimal impact on surrounding healthy tissue. Moreover, pre-clinical observation have shown that photoimmunotherapy may also stimulate both innate and adaptive anti-tumor immune responses.<\/p>\n<p>\u201cRakuten Medical\u2019s Alluminox\u2122 platform has the potential to transform cancer therapy in the U.S.,\u201d said Maeda. \u201cWe are honored to be recognized by the FDA and invited to contribute to discussions on how regulatory innovation can accelerate the delivery of pioneering treatments to patients. We fully support the FDA\u2019s vision of a modern framework that ensures timely access, safety, and affordability.\u201d<\/p>\n<p><span>Rakuten Medical is currently conducting a global Phase 3 clinical trial evaluating its ASP-1929 photoimmunotherapy in combination with pembrolizumab as a first-line treatment for patients with recurrent head and neck squamous cell carcinoma (HNSCC) (Protocol number: ASP-1929-381 \/ Acronym: ECLIPSE \/ ClinicalTrials.gov Identifier: <\/span><a href=\"https:\/\/clinicaltrials.gov\/study\/NCT06699212\" target=\"_blank\" rel=\"noopener\"><span>NCT06699212<\/span><\/a><span>). A prior Phase 1b\/2 study showed <\/span><a href=\"https:\/\/rakuten-med.com\/us\/news\/press-releases\/2024\/05\/24\/7847\/\"><span>promising interim evaluation results<\/span><\/a><span>, including a 24-month survival rate of 52.4% and a median overall survival (OS) not yet reached. ASP-1929 photoimmunotherapy received the world\u2019s first regulatory approval in Japan under the Conditional Early Approval System based on a certain level of efficacy and acceptable safety from Phase 1\/2a trial results. It is being delivered to patients in Japan at an affordable price.<\/span><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><div id=\"pg-7904-2\"  class=\"panel-grid panel-no-style\"  style=\"margin-bottom: 0px\" ><div id=\"pgc-7904-2-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7904-2-0-0\" class=\"so-panel widget widget_sow-editor panel-first-child panel-last-child\" data-index=\"2\" ><div class=\"panel-widget-style panel-widget-style-for-7904-2-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-editor so-widget-sow-editor-base\"\n\t\t\t\n\t\t>\n<div class=\"siteorigin-widget-tinymce textwidget\">\n\t<p><i><span style=\"font-weight: 400\">Disclaimer: Rakuten Medical\u2019s Alluminox\u2122 platform-based photoimmunotherapy is investigational outside Japan.<\/span><\/i><\/p>\n<p><b>About Rakuten Medical, Inc.<br \/>\n<\/b><span style=\"font-weight: 400\">Rakuten Medical, Inc. is a global biotechnology company developing and commercializing Alluminox\u2122 platform-based photoimmunotherapy, which, in pre-clinical studies, has been shown to induce rapid and selective cell killing. Rakuten Medical\u2019s photoimmunotherapy is currently investigational outside Japan. Rakuten Medical is committed to its mission to conquer cancer by developing its pioneering treatments as quickly as possible to as many patients as possible all over the world. The company has offices in 5 countries\/regions, including the United States, where it is headquartered, Japan, Taiwan, Switzerland and India. For more information, visit <\/span><a href=\"http:\/\/www.rakuten-med.com\"><span style=\"font-weight: 400\">www.rakuten-med.com<\/span><\/a><span style=\"font-weight: 400\">.<\/span><\/p>\n<p><b>About Alluminox\u2122 platform<br \/>\n<\/b><span style=\"font-weight: 400\">The Alluminox\u2122 platform is Rakuten Medical\u2019s investigational technology platform that combines pharmaceuticals, medical devices, medical technology, and other peripheral technologies. Rakuten Medical is developing Alluminox platform-based photoimmunotherapy, which involves two key steps: 1) drug administration and 2) targeted illumination using medical devices. The drug component consists of a cell-targeting moiety conjugated to a light-activatable dye, such as IRDye\u00ae 700DX (IR700), that selectively binds to the surface of targeted cells, such as tumor cells. The device component consists of a light source that locally illuminates the targeted cells with red light (690nm) to transiently activate the drug. Rakuten Medical\u2019s pre-clinical data have shown that this activation elicits rapid and selective necrosis of targeted cells through a biophysical process that compromises the membrane integrity of the targeted cells. Therapies developed on the Alluminox platform may also result in local and systemic innate and adaptive immune activation due to immunogenic cell death of the targeted tumor cells and\/or the removal of targeted immunosuppressive cells within the tumor microenvironment. Photoimmunotherapy was originally developed by Dr. Hisataka Kobayashi and his team at the National Cancer Institute in the United States. Outside Japan, Rakuten Medical\u2019s Alluminox platform-based photoimmunotherapy is investigational.<\/span><\/p>\n<p><b>About ASP-1929<br \/>\n<\/b><b><\/b><span style=\"font-weight: 400\">Rakuten Medical\u2019s first pipeline drug developed on its Alluminox\u2122 platform is ASP-1929, an antibody-dye conjugate comprised of the anti-EGFR antibody cetuximab and IRDye\u00ae 700DX, a light activatable dye. ASP-1929 binds to epidermal growth factor receptor (EGFR), a cancer antigen expressed in multiple types of solid tumors, including head and neck, breast, lung, colorectal, prostate and pancreatic cancers. After binding to cancer cells, ASP-1929 is locally activated by illumination with red light (690 nm), emitted by a laser device system to produce a photochemical reaction. This reaction is believed to cause damage to the membrane of cancer cells, leading to selective necrosis of cancer cells. In Japan, ASP-1929 received marketing approval from the Japanese Ministry of Health, Labor, and Welfare for unresectable locally advanced or recurrent head and neck cancer in September 2020, under the Sakigake Designation System and the Conditional Early Approval System. ASP-1929 photoimmunotherapy in combination with pembrolizumab is currently under investigation in a global Phase 3 clinical trial as a first-line therapy for recurrent head and neck cancer. Outside Japan, ASP-1929 has not yet been approved for commercial use by any regulatory authority.<\/span><\/p>\n<p>&nbsp;<\/p>\n<p><a href=\"https:\/\/www.prnewswire.com\/news-releases\/rakuten-medical-selected-to-participate-in-fda-ceo-forum-in-san-diego-302481119.html?tc=eml_cleartime\" target=\"_blank\" rel=\"noopener\">PR Newswire<\/a><\/p>\n<\/div>\n<\/div><\/div><\/div><\/div><\/div><div id=\"pg-7904-3\"  class=\"panel-grid panel-no-style\" ><div id=\"pgc-7904-3-0\"  class=\"panel-grid-cell\" ><div id=\"panel-7904-3-0-0\" class=\"so-panel widget widget_sow-button panel-first-child panel-last-child\" data-index=\"3\" ><div style=\"padding: 30px 0px 0px 0px;\" class=\"panel-widget-style panel-widget-style-for-7904-3-0-0\" ><div\n\t\t\t\n\t\t\tclass=\"so-widget-sow-button so-widget-sow-button-flat-6fd36f18507f-7904\"\n\t\t\t\n\t\t><div class=\"ow-button-base ow-button-align-center\"\n>\n\t\t\t<a\n\t\t\t\t\thref=\"https:\/\/rakuten-med.com\/us\/contact\/\"\n\t\t\t\t\tclass=\"rakuten-btn sowb-button ow-icon-placement-left ow-button-hover\" \t>\n\t\t<span>\n\t\t\t\n\t\t\tContact Us\t\t<\/span>\n\t\t\t<\/a>\n\t<\/div>\n<\/div><\/div><\/div><\/div><\/div><\/div>","protected":false},"excerpt":{"rendered":"<p>Engaged with FDA Commissioner on shared commitment to fast, safe, and affordable patient access to innovative therapies San Diego, CA [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"template":"","meta":{"_acf_changed":false,"_genesis_hide_title":false,"_genesis_hide_breadcrumbs":false,"_genesis_hide_singular_image":false,"_genesis_hide_footer_widgets":false,"_genesis_custom_body_class":"","_genesis_custom_post_class":"","_genesis_layout":""},"class_list":{"0":"post-7904","1":"press_releases","2":"type-press_releases","3":"status-publish","5":"entry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - 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